The present invention relates to pharmaceut ical compositions containing an inhibitor of gastrointestinal lipase, and at least one compound selected from the group consisting of chitosan, its derivatives and salts thereof.
An example of an inhibitor of gastrointestinal lipase is orlistat, previously known as tetrahydrolipstatin or THL. It reduces the absorption of dietary fat. Its use for the control or prevention of obesity and hyperlipaemia, is described in U.S. Pat. No. 4,598,089. Orlistat is the N-formyl-L-leucine ester with (3S,4S)-3-hexyl-4-[(2S)-2-hydroxytridecyl]-2-oxetanone.
Anal leakage of oil (oily spotting) is an adverse effect which is occasionally observed in patients treated with lipase inhibitors. It results from physical separation of some liquid unabsorbed dietary fat from the bulk of the fecal mass in the lower large intestine. This effect can be prevented with the pharmaceutical compositions of the present invention.
In U.S. Pat. No. 5,447,953 it has been demonstrated that by combining a lipase inhibitor with substantial amounts of water insoluble crude fibers, the inhibiting effect on fat absorption can be increased.